Bilateral arm trainer and method of use

ABSTRACT

A device and method for bilateral upper extremity training for patients with a paretic upper extremity, the device facilitating cortical remodeling, sustained relearning and improvement in functional outcomes in paretic and possibly non-paretic upper extremities. In one variation, the device includes a base ( 2 ), an adjustable chest plate ( 31 ) for placing the user at a set distance from the device and isolating arm movement, an incline plate ( 3 ) attached and inclinable relative to the base, two width plates ( 30, 31 ) adjustably attached to the incline plate, and two swivel ( 50, 51 ) plates adjustably attached to the width plates. In one variation, the swivel plates are swivalable relative to a fixed point in a plane parallel to the plane of the width plates. In another variation, the swivel plates are pivotably attached to the width plates. Other features of the device include a counter for counting user activity, and audible and visual cueing devices for facilitating sustained learning.

[0001] This application claims priority to U.S. Provisional PatentApplication S. No. 60/179,511 filed Feb. 1, 2000. The entirety of thatprovisional application is incorporated herein by reference.

[0002] The development of the present invention was supported by theUniversity of Maryland, Baltimore and the University of Maryland MedicalSystem.

BACKGROUND OF THE INVENTION

[0003] 1. Field of the Invention

[0004] This invention relates to a device for bilateral upper extremitytraining for patients with a paretic upper extremity, and morespecifically, to a device providing bilateral upper extremity trainingthat facilitates cortical remodeling, sustained relearning andimprovement in functional outcomes in both the paretic and non-pareticupper extremity, as well as, to a method of using the device toaccomplish sustained re-learning of motor tasks and improved bimanualmotor coordination in individuals with a paretic upper extremity.

[0005] 2. Background of the Technology

[0006] Hemiparesis involving the upper extremity following strokeprofoundly impacts the functional performance of stroke survivors. Thereare an estimated 750,000 strokes each year in the United States alone.Of these, more than 300,000 individuals survive stroke; however, theseindividuals often survive with resultant significant disability. Only 5%of adults regain full arm function following stroke and 20% regain nofunctional use at all (see, e.g., Gowland, C., et al., Agonist andAntagonist Activity During Voluntary Upper-limb Movement in Patientswith Stroke, 72 Physical Therapy 624-633 (1992)). It has been previouslyreported that little change can be facilitated in upper extremityfunction after approximately 11 weeks following stroke (Nakayama, H., etal., Recovery of Upper Extremity Function in Stroke Patients: TheCopenhagen Study, 75 Archives of Physical Medicine and Rehabilitation852-857 (1994)). Recent evidence, however, suggests that improvement infunctional performance of the upper extremity can be seen in patientsbeyond 11 weeks post-stroke. Animal studies indicate that both centralneural remodeling and functional gains can occur long after injury. Forexample, monkey models of chronic stroke demonstrated functionalrecovery, as well as, cortical reorganization after being forced to usetheir paretic limb (see Nudo. R. J., et al., Reorganization of MovementRepresentations in Primary Motor Cortex Following Focal IschemicInfarcts in Adult Squirrel Monkeys, 75 J. Neurophys. 214449 (1996);Nudo, R. J., et al., Use-Dependent Alterations of MovementRepresentations in Primary Motor Cortex of Adult Squirrel Monkeys, 16 J.Neurosc. 785-807 (1996); Nudo, R. J., et al., Neural Substrates for theEffects of Rehabilitative Training on Motor Recovery After IschemicInfarct, 272 Science 17914 (1996)). The expansion of cortical mapscorresponds to both the affected and non-affected limbs.

[0007] While improvement in functional performance of hemipareticpatients is possible, usage of training devices may increase theimprovement. However, most training devices are for aerobic exercise orstrength training; they do not allow for flexible training of naturalactions used in many activities of daily living. The majority of thedevices of the prior art are yoked (connected handles) and driven bymuscle building principles rather than motor control/neuroplasticityprinciples. Such an arrangement allows the stronger upper extremity to“carry” the weaker upper extremity, limiting the stress on and activeinvolvement of the weak arm. Alternatively, other devices of the priorart are designed for unilateral strengthening of the paretic arm whilethe non-paretic limb is constrained. There is increasing evidence thatthe “unaffected” limb following unilateral stroke presents with somedysfunction relating to the loss of neurophysiological linkage in thecentral nervous system. Thus, the devices of the prior art fail torehabilitate the unaffected limb in concert with the paretic limb, whichis essential for many tasks. Bilateral upper extremity training of thepresent invention has the capability to be an effective trainingparadigm to promote agonist muscle activity in the paretic limb and topromote a facilitation effect from the non-paretic to the paretic limb.Furthermore, the device and method of the present invention has thecapability to result in bilateral relearning and cortical remodeling,which improves both intralimb and interlimb coordination and functionaloutcome.

[0008] The specific effects on motor function and coordinationpost-stroke in the upper extremity have been previously evaluated infairly high functioning patients. During reaching and grasping tasks,post stroke subjects presented with segmented movement patternsdemonstrated difficulty with interjoint coordination especiallyinvolving the shoulder and the elbow. When movement times are increasedduring these tasks, adaptive patterns of movement can be seen. Althoughthere are conflicting reports in the literature as to the specificcauses of these differences, it appears that decreased agonistrecruitment and poor sensorimotor control seem to be key factors thatlimit the ability of subjects to carry out these tasks in a smooth andcoordinated fashion. This principle extends to bilateral task specificcoordination, as well.

[0009] While previous reports suggested that little change can befacilitated in upper extremity (UE) function after approximately 11weeks following stroke, other reports suggests that improvement infunctional performance of the upper extremity can be seen in patientswith chronic stroke. For example, it has been demonstrated that improvedfunctional performance can occur in UE functions of chronic strokepatients with forced use of the affected limb and restraint of theunaffected limb (see Ostendorf, C., et al, Effect of Forced Use of theUpper Extremity of a Hemiplegic Patient on the Changes in Function, 61Phys. Ther. 1022-1028 (1981); Wolf, S., et al., Forced Use of HemiplegicExtremities to Reverse the Effect of Learned Nonuse among Chronic Strokeand Head Injured Patients, 104 Exp Neuro.125-132 (1989)). These studiesoffer promise for the rehabilitation of a stroke survivor, but theyinvolve training of a single limb and are restricted to fairly highfunctioning patients.

[0010] For example, in Taub, E., et al., Technique to Improve ChronicMotor Deficit After Stroke, 74 Archives of Physical Medicine andRehabilitation 347-354 (1983) patients were excluded if they could notachieve at least 10 degrees of extension at the metacarpophalangeal andinterphalangeal joints of the hand and 20 degrees of extension at thewrist of the affected limb. Wolf et al. (1989) required subjects to beable to actively initiate wrist and finger extension on the pareticside. This has restricted the success of the forced use paradigm to thehigher functioning patient. Using the present invention, however, apatient with minimal active movement, limited to just the shoulder,demonstrated changes in upper extremity function. Thus, the presentinvention is capable of being used by patients at all levels of recoverypost stroke, providing minimal movement is present.

[0011] In addition, many human physical functions involving the upperextremities are bilateral in nature, and, although each limb may notperform the same specific task, there exists a coordination betweenupper limbs that permits functional efficiency. Therefore, the presentinvention, a bilateral upper extremity exercise training device,facilitates greater improvement of the paretic upper extremity than aunilateral one.

[0012] Finally, as mentioned earlier, evidence shows that the“unaffected” limb following unilateral stroke presents with dysfunctionas well. Limitations have been demonstrated in fine and gross motordexterity, motor coordination, global functional performance, thumbkinesthesia, speed of finger taping and grip strength (Desrosiers, J.,et al., Performance of the ‘Unaffected’ Upper Extremity of ElderlyStroke Patients, 27 Stroke 1564-70 (1996); Prigatano, G., et al., Speedof Finger Tapping and Goal Attainment After Unilateral Cerebral VascularAccident, 78 Archives of Physical Medicine and Rehabilitation 847-852(1997)). This suggests a potential benefit to both upper extremitieswith bilateral versus strict unilateral training of the upperextremities post-stroke.

[0013] No studies have been done evaluating the effectiveness of anexercise intervention for post-stroke hemiplegia where training involvesboth upper extremities at the same time. Training in this context mayhelp the neuromuscular system to use the extremities in a morecoordinated fashion that will not only improve motor performance of thehemiplegic upper extremity but may impact functional outcomes of bothlimbs as well. For example, Gauthier, et al. (1994) demonstratedimprovement in the muscle activity and torque production of thehemiplegic lower extremity through training that included resistiveexercise of the “unaffected” lower extremity. This provides evidencethat the use of bilateral training can be an effective trainingmechanism for the motor performance of the lower extremity. Otherstudies have also demonstrated functional gains in bilateral training ofthe lower extremities using a treadmill or walking protocols.

[0014] Most currently used rehabilitation therapies require the presenceof a therapist; patients can not use such therapies on their own.Alternatively, robotic therapy devices are complex, bulky and expensive.None of the physical therapy or exercise devices currently availabledisclose a simple, portable, non-motorized, adjustable and independentbilateral limb trainer.

SUMMARY OF THE INVENTION

[0015] It is an advantage of the present invention to provide a novelunyoked bilateral upper extremity exercise device to promote agonistmuscle activity in the paretic limb and the relearning of sensorimotorrelationships during task specific limb function.

[0016] It is another advantage of the present invention to mimic naturalhuman physical functions involving unilateral and bilateral simultaneousor alternating activities of the upper extremities in a variety ofpositions.

[0017] It is a further advantage of the present invention to provide aportable, versatile and inexpensive bilateral upper extremity exercisedevice for post-stroke hemiparesis to use without requiring the presenceof a therapist. It is yet a further advantage to construct the devicefrom lightweight materials, such as lucite, wood, metal, and/or carboncomposites, or other lightweight materials so that the device is easilyportable.

[0018] It is a further advantage of the present invention that thedevice have straight tracks or curved tracks, permitting the upper limbsto move in a variety of positions and directions. The use of differentpatterns of movement in the training program may invoke the motorlearning principle of contextual interference. Changing one's movementis known to increase the learning and retention of those movements. Withthe device and method of the present invention, users reconstruct musclesynergy patterns with a concomitant change of attentional focus andenhanced learning.

[0019] It is a further advantage of the present invention that thedevice have various angles in the transverse through frontal planes. Itis yet another advantage of the present invention that the devicepermits movement in various directions in various planes relative to theperson using the device.

[0020] It is another advantage of the present invention that peoplesuffering from diminished control of their shoulder(s), arm(s),elbow(s), forearm(s), hand(s), wrist(s), or finger(s) are able to usethis device to improve the function and control over their shoulder(s),arm(s), elbow(s), forearm(s), hand(s), wrist(s), and finger(s).

[0021] It is a further advantage of the present invention that thedevice is adjustable to accommodate users of various stature, as wellas, for a range of motion for each user.

[0022] It is another advantage of the present invention to improve thecontrol, flexibility, and/or range of motion of the shoulder(s), arm(s),elbow(s), forearm(s), hand(s), wrist(s), and finger(s) of the user.

[0023] It is another advantage of the present invention to have acounter or a tracker of usage so that one is able to confirm usage ofthe device in a setting other than under the supervision of a physicaltherapist, physician, nurse, trainer, medical personal, or other type ofsupervisor.

[0024] It is another advantage of the present invention to provide anauditory or visual stimulus for feedback. The beat of a metronome and/orthe mirrored reflection of the participant's movements provide a form ofintrinsic feedback to the participant, who is able to judge thereby howaccurate they are in performing the task, as well as, focusing attentionon the timing of the beat, the reflected movement, and the end-points ofthe reaching movements. Both are important for motor learning. It is afurther advantage of the present invention to provide an auditory orvisual stimulus for goal setting, which is another major fundamentalprinciple of motor learning.

[0025] It is an advantage of an embodiment of the present invention thatthe device provides little or no resistance with regard to movement ofhandles within the tracks. It is yet another advantage that the littleor no resistance of the handles within the tracks occurs by use ofrollers, wheels, or other features for minimizing resistance tomovement.

[0026] It is an advantage of the device of another embodiment of thepresent invention that weights and resistance may be added forfacilitating relearning of bimanual movements that mimic the behavior ofreaching and bringing objects toward the user. It is a further advantageof the present invention that strength training of one or both upperextremities can be accomplished with the device.

[0027] It is further an advantage that the handles can be yoked orunyoked. The advantages of an unyoked device have been described above.Under some circumstances yoking the handles of the device of the presentinvention may additionally facilitate sensorimotor relearning necessaryfor controlled and coordinated bimanual activities.

[0028] It is yet another advantage of the present invention thatsensorimotor relearning is enhanced using shorter and more frequenttraining periods and less dependence on conditioning effects thandevices and methods of the prior art.

[0029] An embodiment of the present invention comprises a portable armcontrol training device that has two unyoked handles that are capable oftraveling along straight or curved tracks at various angles intransverse through frontal planes. In one embodiment, the handles movealong the tracks without or with little resistance, such littleresistance being accomplished through the use of rollers wheels, orother devices for minimizing friction or other resistance. In anotherembodiment, weights or resistance are addable to the handle movementalong the tracks, to facilitate relearning or to add strength training.

[0030] The present invention is specifically designed for use with thepost-stroke population, but also potentially has more general use withother populations (e.g., patients suffering from head injuries, braintumors, cerebral palsy). The present invention's various modularfeatures make it useable by individuals of different stature and bodyhabitus, and with different capabilities, depending on the severity ofthe paresis. The present invention's various modular features permitpeople with a range of limb control control to use the device.

[0031] The present invention's modular design, as well as itsconstruction from lightweight materials, such as lucite, wood, metals,carbon composites, and/or other lightweight materials, makes itportable, flexible, easy to use, versatile and inexpensive. Thus, thepresent invention may be used by individuals with a paretic upperextremity without the presence of a therapist.

[0032] The present invention offers a novel exercise intervention forpost-stroke hemiparesis resulting from, for example, stroke, headinjuries, brain tumors, or cerebral palsy, where training involves bothupper extremities at the same time. Thus, training with the presentinvention helps the neuromuscular system to relearn control theextremities in a more coordinated fashion that not only improves motorperformance of the paretic upper extremity but impacts functionaloutcome of both upper extremities.

[0033] To achieve the stated and other advantages of the presentinvention, as embodied and described below, the invention furtherincludes a device for bilateral upper extremity training, comprising: abase; a pair of sliding tracks attached to the base; and a pair ofhandles slidably movable along the sliding tracks, wherein the handlesare unyoked and have minimal resistance for movement along the tracks.

[0034] To achieve the stated and other advantages of the presentinvention, as embodied and described below, the invention furtherincludes a device for bilateral arm training for a user, comprising: apair of connected swivel plates, each of the swivel plates beingindependently swivelable about a point on the swivel plate, such thateach of the swivel plates may be swiveled to a selected angle, whereinthe connected pair of swivel plates has a first end and a second end; apair of sliding tracks attached to the pair of swivel plates; a pair ofhandles slidably movable along the sliding tracks; an incline deviceconnected to the first end of the pair of swivel plates, such that thepair of swivel plates may be inclined relative to the second end of thepair of swivel plates; and a user distancing device connected to thesecond end of the pair of swivel plates, the user distancing device formaintaining the user at a set distance while the user grasps the pair ofhandles; wherein the pair of sliding tracks may be adjusted byinclination of the pair of swivel plates and by swiveling of the pair ofswivel plates, such that a variable range of motions may be made by theuser via the pair of handles.

[0035] To achieve the stated and other advantages of the presentinvention, as embodied and described below, the invention furtherincludes a bilateral arm trainer for a user, comprising: a basesecurable to a fixed surface; an incline plate pivotably attached to thebase; a first width plate and a second width plate, the first widthplate and the second width plate being adjustably attached to theincline plate; a first swivel plate and a second swivel plate, the firstswivel plate being attached to the first width plate and the secondswivel plate being attached to the second width plate, wherein the firstswivel plate is swivelable about a first swivel plate point relative tothe first width plate, and wherein the second swivel plate is swivelableabout a second swivel plate point relative to the second width plate; afirst track attached to the first swivel plate and a second trackattached to the second swivel plate; a first handle movable along thefirst track and a second handle movable along the second track; anincline device for pivotably inclining the incline plate relative to thebase; and an adjustable chest rest attached to the base for maintainingthe user at a set distance while the user grasps the pair of handles;wherein the first track and the second track are adjustable byinclination of the incline plate and swiveling of the first swivel plateand the second swivel plate, such that a variable range of motions maybe made by the user via the pair of handles.

[0036] To achieve the stated and other advantages of the presentinvention, as embodied and described below, the invention furtherincludes a bilateral arm trainer for a user, comprising: a basesecurable to a fixed surface; an incline plate pivotably attached to thebase; a first width plate and a second width plate, the first widthplate and the second width plate being adjustably attached to theincline plate; a first swivel plate and a second swivel plate, the firstswivel plate being attached to the first width plate by a first swivelplate pivoting device and the second swivel plate being attached to thesecond width plate by a second swivel plate pivoting device, wherein thefirst swivel plate is pivotable relative to the first width plate, andwherein the second swivel plate is pivotable relative to the secondwidth plate; a first track attached to the first swivel plate and asecond track attached to the second swivel plate; a first handle movablealong the first track and a second handle movable along the secondtrack; an incline device for pivotably inclining the incline platerelative to the base; and an adjustable chest rest attached to the basefor maintaining the user at a set distance while the user grasps thepair of handles; wherein the first track and the second track areadjustable by inclination of the incline plate and pivoting of the firstswivel plate and the second swivel plate, such that a variable range ofmotions may be made by the user via the pair of handles.

[0037] To achieve the stated and other advantages of the presentinvention, as embodied and described below, the invention furtherincludes a method for cortical remodeling and sensorimotor relearningfor a person suffering from neurological damage caused by one from agroup consisting of stroke, tumor, and injury, the neurological damageresulting in diminished movement of at least one upper body extremity,the method comprising: moving a pair of unyoked handles along a pair ofsliding tracks, wherein the sliding tracks are attached to a base,wherein the handles move with a minimum of resistance along the slidingtracks for a period of time, and wherein the moving of the pair ofunyoked handles unmasks neural pathways.

[0038] Additional advantages and novel features of the invention will beset forth in part in the description that follows, and in part willbecome more apparent to those skilled in the art upon examination of thefollowing or upon learning by practice of the invention. While the nameof the device suggests bilateral arm training it should be clear thatthe device is intended for rehabilitation of all joints and muscles ofthe upper limbs. Use of the term arm is intended to include the entireupper extremity.

BRIEF DESCRIPTION OF THE FIGURES

[0039] In the drawings:

[0040]FIG. 1 presents an overhead view of a bilateral arm trainer inaccordance with an embodiment of the present invention;

[0041]FIG. 2 shows an overhead view of the bilateral arm trainer of FIG.1 with swivel plates partially swiveled to angles φ₂ and φ₁;

[0042]FIG. 3 is an end view of the bilateral arm trainer of FIG. 1;

[0043]FIG. 4 presents a side view of the bilateral arm trainer of FIG.1;

[0044]FIG. 5 presents the side view of the bilateral arm trainer of FIG.1 with the inline plate set inclined by angle θ₁ with the base;

[0045]FIG. 6 is an end view of a bilateral arm trainer in accordancewith an embodiment of the present invention in which the swivel platesare pivotable;

[0046]FIG. 7 shows the Fugl Meyer score of 14 patients for a studyperformed using a device in accordance with an embodiment of the presentinvention;

[0047]FIG. 8 presents the Wolf Function score of 11 patients for a studyperformed using a device in accordance with an embodiment of the presentinvention; and

[0048]FIG. 9 shows the UMAQS score of 11 patients for a study performedusing a device in accordance with an embodiment of the presentinvention.

DETAILED DESCRIPTION

[0049] The present invention in use serves as an arm control trainingdevice. It is an improvement in the art of arm ergometry, with differentprinciples concerning bilateral influences on motor control. The presentinvention offers a novel and useful exercise intervention forpost-stroke hemiparesis where training involves both upper extremitiesat the same time. Bilateral upper extremity training promotes agonistmuscle activity in the hemiparetic arm and facilitates the releaning ofsensorimotor relationships during arm function. Consequently, thepresent invention improves intralimb and interlimb coordination. Thus,training with the present invention may help the neuromuscular system tocontrol the extremities in a more coordinated fashion that not onlyimproves motor performance of the hemiparetic upper extremity but mayimpact functional outcome as well.

[0050] The present invention, a bilateral upper extremity physicalexercise training device, is specifically designed for patients who aresuffering from hemiparesis or whose motor control is affected due tocerebral palsy, stroke, tumor, head injury, etc. One embodiment of thepresent invention includes two unyoked handles that travel alongstraight, or, alternatively, curved tracks at various angles intransverse and frontal planes. In one embodiment, the handles move alongthe tracks without or with little resistance, such little resistancebeing accomplished through the use of rollers, wheels, or other devicesfor minimizing friction or other resistance. Its various modularfeatures and lightweight construction, using materials such as lucite,wood, metals, carbon composites, or other lightweight materials make ituseable by different sized people and with different capabilitiesdepending on the severity of the stroke. Its various modular featuresmake it useable by people with various levels of control of their upperextremity including shoulder(s), elbow(s), wrist(s), and finger(s). Thisdevice is designed to facilitate the remapping and/or the unmasking ofdormant neuromuscular pathways. One advantageous utility is forregaining motor control or motor re-learning, rather than strengthtraining. Though not intended as an aerobic exerciser, the presentinvention is capable of being modified, in some embodiments, to provideaerobic training by adding weights, resistance, yoke, etc., and thus isusable for strength training. The addition of weights, resistance or ayoking device further assists in unmasking neural patterns lost duringnon-use of the paretic upper extremity.

[0051] The present invention is functionally oriented, mimics everydayactivities, and can be instrumented to study movement and improvement.Its flexible apparatus, such as yoked versus unyoked, different angles,modified handles, change of arm positions, etc., allows for variablefunctional movement. It is dimensionally adjustable, scalable forpatients of different stature and habitus and is very portable. Thepresent invention fills a void for chronic stroke victims, a previouslyuntreated group, by providing a bilateral upper extremity trainingdevice that has the capability to improve their upper extremity functionand thereby improve their quality of life.

[0052] In some embodiments, the present invention can be elevated to avariety of positions, upward and downward, relative to the user's chestto provide for a range of movements and therapy. It can be tilted orangled to a variety of positions, upward and downward, relative to theuser's chest to provide for a range of movements and therapy. Whenelevated or angled upward or downward, the chest rest can be adjusted sothat the chest rest is positioned correctly relative to the user.

[0053] In an alternative embodiment, the apparatus has curved tracks.Curved tracks are useful for certain movements of the shoulder.

[0054] In another alternative embodiment the apparatus has spherical,discus-shaped, square, circular, oval, or other shaped knobs as handles,the shape being conducive for use for bilateral upper extremitytraining. The knobs can be of various thickness and overall size forcomfort for the user. The knobs are attached in manners well known inthe art, such that the knobs can turn freely in clockwise andcounter-clockwise directions. The knobs can turn without resistance orwith resistance. The knobs can be yoked or unyoked. This alternativeembodiment permits the user to practice and exercise movements of thewrists and forearms, in supination and pronation movements.

[0055] Another alternative embodiment utilizes wrist-handles that areattachable to the user's wrists. This embodiment frees up the fingers sothat the user can exercise/move the fingers while moving the arms.

[0056] In yet another alternative embodiment of the device, a tracker orcounting device is attached to either the handles or the tracks. Thetracker or counter maintains count or track of the number of times theuser performs the exercise or movement. It is also able to track thetime of day. In some embodiments the tracker or counter stores theinformation in memory, using devices and methods known in the art, andis able to print out or export the information in a readable format atthe convenience of the person supervising the exercise or training. Insuch a manner the person supervising the training does not have to be atthe user's side each time the device is used.

[0057] In another embodiment of the device, an auditory or visualstimulus is added to the device so that the user receives feedback fromthe usage of the device or obtains goal setting information. An auditorystimulus includes, for example, a metronome or an audio recording. Avisual stimulus includes, for example, a visual display component, suchas a monitor screen, television, mirror, or other device containinginformation on goal setting, performance, or usage of the device.

[0058] In another alternative embodiment of the device, resistance isadded to the movement of the handles, tracks, or slides. Alternatively,weights are added to the handles, tracks, or slides. In theseembodiments, the device is also used to strengthen the user's muscles.Furthermore, the handles may be yoked when this type of training isdeemed advisable.

[0059] By changing the elevation, position, and tracks (straight orcurved), type of handles, in accordance with these and variousembodiments, one can improve the control, functional use of, strengthand active range of motion of the arm(s), hand(s), fingers and/orwrist(s) of the user.

[0060] References will now be made in detail to embodiments of thepresent invention, examples of which are illustrated in the accompanyingdrawings.

[0061] As shown in FIGS. 1-5, the bilateral arm trainer 1 has a base 2that rests on a flat surface, such as the top surface of a table, desk,counter, or similar furniture. The base 2 is detachably securable to thesurface via, for example, clamps, suction cups, screws, nails, or othersimilar mechanisms. It is preferable to secure the bilateral arm trainer1 to the surface in order to prevent movement of the entire apparatusduring usage. Gravity and friction also act to keep the apparatus 1 onthe surface if the apparatus 1 of the embodiment employed is ofsufficient weight for such use and, for example, if the surface is nottoo slippery. Also, a non-skid pad is optionally placeable between thedevice 1 and the surface to assist in maintaining the device 1 in place.Because the device 1 is preferably light weight for easy transport, insome applications, it is preferable to use clamps or suction cups tosecure the apparatus 1 to the surface and to avoid making holes in thesurface and the device 1.

[0062] In an embodiment of the present invention, an incline plate 3 issecurely attached to the base 2 via one or more hinges 4 or similartypes of mechanisms. When a hinge 4 is used, the hinge 4 is placed onthe edges of the base 2 closest to the user. Thus, the portion of theincline plate 3 furthest from the user is capable of being elevatedupward relative to the base 2, thereby generating an angle ofinclination 0, between the base and the incline plate. This angle ofinclination θ₁ is variable between θ₁ and 90°, most preferably between0° and 45°.

[0063] In accordance with embodiments of the present invention, thereare several different mechanisms to keep the angle of inclination θ₁constant during usage of the invention. In one embodiment, blocks ofvarying heights are placeable between the base 2 and the incline plate 3at a pre-determined location. The incline plate 3 rests on the blocks inthis embodiment. Depending on the height of the blocks and the locationof their placement, one is able to create a known angle of inclinationθ₁. A more preferable method is to use a height rod 10, which isattached to the base 2 via a plate or other attachment device 13 at theback of the base 2, furthest from the user. In one embodiment, theheight rod 10 has notches in it at pre-determined positions along thelength of the height rod 10. A latching bar, which is attached to theincline plate 3, is placeable in the notches on the height rod. Thus,the latching bar is detachably securable to the height rod 10 at aspecific location along the height rod 10, thereby to generate a knownangle of inclination θ₁.

[0064] In an alternative embodiment, the height rod 10 has visiblemarkings along its length at predetermined spacings. The height rod 10transverses a height tube 11, which is attached to the incline plate 3,through an opening in the height tube 11. The height tube 11 alsocontains a threaded hole into which a screw clamp 12 is threaded. Theend of the screw clamp 12 rests against the height rod 10 when the screwclamp 12 is screwed into the threaded hole, thereby securing theposition of the height rod 10 in the height tube 11. The screw clamp 12is unscrewably releaseable, such that the position of the height rod 10is adjustable within the height tube 11, and then the screw clamp 12 isscrewably securable to secure the height rod 10 inside the height tube11. The angle of inclination θ₁ is thereby adjustable. The visiblemarkings along the height rod 10 allow the angle of inclination θ₁ to beset at known angles. In one embodiment, the height rod 10 is pivotableat the attachment device 13, such as about a pin 14 extending throughthe attachment device 13.

[0065] For both embodiments the incline plate 3 is shaped such that theincline plate 3 is able to rest flat on the base 2 when the angle ofinclination θ₁ is 0° (i.e., the screw thread 12 and the height tube 10or the latching bar do not interfere with the resting of the inclineplate 3 on the base 2).

[0066] In an embodiment of the present invention, attached to the frontof the base 2 is a user distancing device, such as or including anadjustable chest rest 20. The chest rest 20 keeps the user's chest apre-determined distance d, away from the front of the base 2 andstabilizes the user's trunk to isolate arm movement. The distance d₁away from the front of the base 2 and the height h of the chest rest 20are adjustable to accommodate users with different body sizes and armlengths. The chest rest 20 has a chest plate 21 that is shapable in oneembodiment, but preferably has a flat surface against which the userrests the user's chest. The chest plate 21 is attached to a distancepole 22 via, for example, a ball-and-socket joint 23 to permit freemovement of the chest plate 21. The distance pole 22 extends through anopening in the distance pole connector 24 which is attached to the topof a height pole 26. In one embodiment, the distance pole connector 24also has a threaded hole and a screw clamp 25 that are usable to securethe distance pole 22 into position via pressure of the screw extensionagainst the distance pole 22. The screw clamp 25 is unscrewable, suchthat the position of the distance pole 22 relative to the hole in thedistance pole connector 24 is adjustable to a desired position. Thescrew clamp 25 is then tightened to secure the distance pole 22 into thedesired position. In one embodiment, the distance pole 22 has visiblemarkings on its surface so that the distance pole 22 is capable of beingset at a predetermined position.

[0067] The height pole 26 is adjustably attached to the base 2 so thatthe height h of the chest plate 21 may be adjusted. A height pole plate27 is securely attached to the base 2. The height pole plate 27 containsan opening through which the height pole 26 transverses. The height poleplate 27 also includes a threaded hole into which a screw clamp 28 isscrewed. The screw clamp 28 holds the height pole 26 into position viapressure by resting against the height pole 26. The screw clamp 28 isunscreweable, such that the position of the height pole 26 along thehole may be adjusted relative to the height pole plate 27, and the screwclamp 28 is then tightened to secure the height pole 26 into a desiredposition at height h. In one embodiment, the height pole 26 includesvisible markings so that the height pole 26 may be set at apredetermined position.

[0068] In an embodiment of the present invention, the incline plate 3includes one or more recesses 5, such that the height pole plate 27 doesnot interfere with the adjustment of the incline plate 3 into variouspositions. Furthermore, the lengths of the height pole 26 and thedistance pole 22 are variable such that the height pole 26 and thedistance pole 22 do not interfere with the adjustment of the inclineplate 3 into various positions. Alternatively, the incline plate 3 hascut-outs to prevent the incline plate 3 from contacting the distancepole 22 or the height pole 26.

[0069] In alternative embodiments, different types of clamps are used tosecure the distance pole 22 and the height pole 26 into desiredpositions. Other embodiments provide for use of alternative types ofdistance spacers and height spacers for maintaining the user at apredetermined distance d₁ from the apparatus.

[0070] A pair of width plates 30, 31 rest on the incline plate 3 in anembodiment of the present invention. The width plates 30, 31 are securedto the incline plate 3 via one or more screw connectors 32, 33, 34, 35or other securing mechanisms for each width plate 30, 31. Each widthplate 30, 31 has two width slots 36, 37, 38, 39; one screw connector 32,33, 34, 35 travels through one width slot 36, 37, 38, 39, respectively.In one embodiment, the incline plate 3 has threaded openings positionedbeneath the width slots 36, 37, 38, 39. The screw connectors 32, 33, 34,35 have threads that extend through the width slots 36, 37, 38, 39,respectively, into the corresponding threaded openings in the inclineplate 3. The two width slots 32, 33 and 34, 35 for a given width plate30, 31, respectively, are parallel to each other. Upon loosening of thetwo screw connectors 32, 33 or 34, 35 for each width plate 30 or 31,that width plate 30 or 31 is slidable to the right or left to themaximum distance allowed by the length of the width slots 32, 33 or 34,35, as viewed in FIG. 1. Then the two screw connectors 32, 33 or 34, 35are tightened to secure the width plate 30 or 31 to the incline plate 3.While adjusting the position of a width plate 30 or 31 care must betaken not to remove the screw connector 32, 33, 34, or 35 entirely fromthe incline plate 3. The sliding movement of the screw connectors 32,33, 34, 35 within the slots 36, 37, 38, 39, respectively, allows the twowidth plates 30, 31 to be moved closer together or further apart fromeach other to the minimum and maximum distances apart allowed by thewidth slots 36, 37, 38, 39. Thus, the distance between the handles 40,41 is variable via attachments among the swivel plates 50, 51 andsliding tracks for slidably moving the handles 40, 41. In oneembodiment, these sliding tracks, which include movement rods 60, 61,movement blocks 70, 71, friction reduction plates 80, 81, and attachmentbars 90, 91, 92, 93, are capable of being adjusted so that the distancefrom each handle 40, 41 to the chest plate 21 is comfortable for theuser. Often the distance between the handles 40, 41 depends on theshoulder width of the user. The width plates 30, 31 are mirror-images ofeach other.

[0071] In an embodiment of the present invention, one swivel plate 50,51 rests on each width plate 30, 31, respectively. The movement rods 60,61 are securely attached to the swivel plates 50, 51, respectively, viatwo attachment bars 90, 92 and 91, 93, respectively, and via frictionreduction plates 80, 81; one attachment bar 90, 92 and 91, 93 is locatedat each end of each movement rod 60, 61, respectively. Each movement rod60, 61 is traversed by a movement block 70, 71, respectively. Themovement blocks 70, 71 are movable along the length of the movementrods, 60, 61, respectively. In one embodiment, a linear bearing (e.g., abearing produced by Walzlager of Germany) is located in the middle ofeach movement block 70, 71. The movement rods 60, 61 travel through therespective linear bearings. Because of the ball bearings within thelinear bearings, each movement block 70, 71 travels with a minimum offriction along each movement rod 60, 61, respectively. In anotherembodiment, as shown in FIG. 4, each movement block 70 or 71 has a wheel72 or other friction reducing or stabilizing features for minimizingresistance with respect to friction reduction plates 80, 81 or otherwiseenhancing use. Alternatively, a variable friction device or weights areusable so as to provide resistance with respect to movement of movementblocks 70, 71.

[0072] Friction reduction plates 80, 81 are attached to the swivelplates 50, 51 beneath the movement rods 60, 61 and beneath the movementblocks 70, 71. In one embodiment the friction reduction plates 80, 81have coatings applied that reduce the friction between the plates 80, 81and the movement blocks 70, 71. One such type of coating is Teflon® madeby DuPont E. I. De Nemours & CO of Wilmington, Del.

[0073] Movement stops 95, 96 are attached to the movement rods 60, 61.The movement stops 95, 96 are adjustable to any point along the movementrods 60, 61 and securable at any position along the rods 60, 61. Themovement stops 95, 96, prevents the movement blocks 70, 71 from beingmoved beyond the movement stops 95, 96. In one embodiment, each movementstop 95, 96 has a rubber-like coating on the side against which themovement block 70, 71, respectively, touches during usage.Alternatively, a rubber-like washer is placeable around each movementrod 60, 61 in front of the movement stops 95, 96 and in front of theattachment bars 92, 93. One advantage of the rubber-like coating orrubber-like washer is muffling or other reduction in the sound producedwhen the movement blocks 70, 71 encounter the movement stops 95, 96 andthe attachment bars 92, 93.

[0074] Similar to the movement stops 95, 96, in an embodiment of thepresent invention, each of the attachment bars located closest to theuser 92, 93, has a rubber-like coating on the side of the attachment bar92, 93 against which the movement blocks 70, 71 touch during usage.Alternatively, rubber-like washers are placeable around the movementrods 60, 61 between the movement blocks 70, 71 and the attachment bars92, 93.

[0075] In an embodiment of the present invention, a mechanical level armcounter 100 (e.g., an arm counter manufactured by Redington Counters,Inc., of Windsor, Conn.) is attached to the movement stop 95 or 96 onone of the swivel plates 50, 51. The counter 100 records each time themovement block 71 reaches the movement stop 96. The counter 100 iscapable of being reset to zero. The user is able to use the counter 100to keep track of the number of repetitions or other event uses of thedevice 1.

[0076] In one embodiment one or both of the movement rods 60, 61 includevisible markings that allow the setting of the movement stops 95, 96 topredetermined positions. In an alternative embodiment, one or both ofthe friction reduction plates 80, 81 have visible markings so that themovement stops 95, 96 can be set to predetermined positions. For bothembodiments, the visible markings do not interfere with the free flowingmovement of the movement blocks 70, 71 along the movement rods 60. 61.

[0077] A handle 40, 41 is attached to the top of each movement block 70,71, respectively. In one embodiment, each handle 40, 41 is T-shaped. Inalternative embodiments, the handles 40, 41 are spherical,discus-shaped, square, oval, circular, or any other shape conducive touse for bilateral upper extremity training. Each handle 40, 41 isscrewed into a movement block 70, 71 so that the handles 40, 41 may beeasily interchanged. The size and shape of each handle 40, 41 is suchthat the handle 40, 41 fits comfortably in the hand of the user or iscomfortable for the user to grasp. A strap is also usable to help hold auser's hand to the handle.

[0078] In one embodiment, each swivel plate 50, 51 is secured to itsrespective width plate 30, 31 via one or more screw connectors 52, 53,54, 55. In this embodiment, the pair of screw connectors closest to theuser 53, 55 travel through openings in the swivel plates 50, 51 intothreaded openings in the width plates 30, 31 directly below the openingsin the swivel plates 50, 51. The second pair of screw connectors 52, 54,which are more distant from the user than the first pair screwconnectors 53, 55, each pass through a slot 55, 56 in the swivel plates50, 51 and into threaded openings in the width plates 30, 31 directlybelow, as best seen in FIG. 1. The slots 55, 56 arc away from the user,such that the portion of each slot 57, 58 that are most distant from theuser are also most distant from the mid-point m₁ of the apparatus 1.When the slot section screw connectors 52, 54 are loosened for eachswivel plate 50, 51, the swivel plates 50, 51 are swivelable in an arcso that the tops of the swivel plates 50, 51, as shown in FIG. 2, swiveloutward from the mid-point m₁ of the apparatus 1. The swivel angles φ₁and φ₂ thereby form, φ₁ being between a line connecting the connectors52, 53 and the end point of the slot 57 in the swivel plate 50, and φ₂being between a line connecting the connectors 54, 55 and the end pointof the slot 58 in the swivel plate 51. The angles φ₁ and φ₂ are variablein the range of about 0° to 90°, most preferably 0° to 45°.

[0079]FIG. 6 presents a variation of the embodiment shown in FIGS. 1-5.As shown in FIG. 6, each swivel plate 50, 51 is hinged to the widthplate 30, 31 below each swivel plate 50, 51, along the outer edge of theswivel plate 50, 51 and the width plate 30, 31. This hinge permits eachswivel plate 50, 51 to be pivoted upward relative to the width plates30, 31 on pivoting devices 110, 111, such as hinges attaching swivelplates 50, 51 to width plates 30, 31, respectively. The angles betweenthe swivel plates 50, 51 and the width plates 30, 31 are called theswivel angles. The swivel angles range from about 0° to 90°. A number ofholding devices are usable in accordance with this embodiment tomaintain the pivoted swivel plates 50, 51 in angled positions. Forexample, in the embodiment shown in FIG. 6, height rods 120, 121attached to width plates 30, 31 by attachment devices 122, 123 extendthrough height tubes 124. 125 attached to swivel plates 50, 51. Screwclamps 126, 127, for example, are used in conjunction with the heighttubes 124, 125 to hold the swivel plates 50, 51 at selected anglesrelative to the width plates 30, 31. In one embodiment, the height rods120, 121 are pivotable at the attachment devices 122, 123, such as aboutpins 128, 129 extending through the attachment devices 122, 123.

[0080] In an embodiment of the present invention, a carrying strap issecurely attached to the base 2 at one side of the base so that it doesnot interfere with the movement of the rest of the apparatus 1. Thecarrying strap is used to move the device.

[0081] When a patient uses the bilateral arm trainer, the patient isseated comfortably at, for example, a table in front of the device 1with the following limb positions: ankles in neutral dorsiflexion, kneesand hips placed at 90°, shoulders in 0° flexion, elbows in 60° flexion,and wrists in neutral position of flexion/extension. The width plates30, 31 are adjusted so that the user is able to comfortably hold thehandles 40, 41. In most circumstances, the width plates 30, 31 areadjusted so that the movement blocks 70, 71 are approximately alignedwith the user's shoulders, the alignment being along the lengthwise axisof the movement rods 60, 61.

[0082] In operation, the patient grasps the handles 40, 41, or theaffected hand is strapped to the handle 40, 41 depending on the severityof the deficits. By using shoulder flexion/protraction and elbowextension the handles 40, 41 are pushed away from the patient, and then(using shoulder extension/retraction and elbow flexion) pulled towardsthe patient's body. This action mimics the behavior of the patientreaching and bringing an object to the patient. When necessary anassistant provides minimal assistance for the affected arm, such as tohelp with the arm extension. On some occasions, the assistance isparticularly useful for the purpose of keeping the elbow from impactingthe table. The movement stops 95, 96 are adjusted so that the movementblocks 70, 71 are unable to travel further than the user can reach andto provide sensorimotor feedback and a goal for the patient.

[0083] In a nonrandomized pilot study performed using a device inaccordance with an embodiment of the present invention, and particularlyin accordance with the embodiments shown in FIGS. 1-5, the effects ofsix weeks (18 therapist hours) arm training on 14 patients with chronichemiparetic stroke both immediately after training and after a retentionperiod were investigated. The study produced surprisingly successfulresults.

[0084] Bilateral arm training for four 5-minute bouts per session wasperformed using the device of the present invention with no weights orother resistance to arm motion. The following measurements were taken:The Fugl-Meyer Upper Extremity Motor Performance Test which measuresimpairments; the Wolf Motor Function Test which measures timedfunctional ability and the University of Maryland Arm Questionnaire forStroke (UMAQs), which measures daily use. Isometric strength and rangeof motion (ROM) measures were also taken.

[0085] Patients showed significant and durable increases in theFugl-Meyer (p<0.0004) (see FIG. 7), the Wolf time test (p<0.02) (SeeFIG. 8) and the UMAQS (p<0.002) (See FIG. 9). Isometric strength wasimproved only in shoulder extension for the affected limb and elbowflexion/grip strength in the less affected limb. Active ROM for thumbopposition (affected) and passive ROM for shoulder extension(unaffected) were also significantly improved.

[0086] Six weeks of bilateral arm training improved both impairments andfunctional use of the paretic limb with very few concomitant changes inisometric strength and ROM. These results were surprising compared tothe prior art, given that the following additional details relating tothe study were used. In the study, researchers employed the well-knownprinciples of forced-use and task-specificity, but did not employ thecommonly used concept of constraining the non-paretic arm. Specifically,the use of bilateral, repetitive rhythmic reaching and retrievingactions was forced using a metronome to cue the patients.

[0087] Auditory cueing has been used successfully to promote immediateand post training gait changes over and above those produced by gaittraining alone in sub-acute stroke patients. Indeed, bilateral armtraining, including such training provided in conjunction with rhythmicauditory cueing, has more in common with current gait (leg) rather thanarm training paradigms, except for at least one important feature: gaittraining paradigms typically have some element of physical conditioningthat may produce exercise-mediated cardio-vascular or musculoskeletaladaptations that could contribute to improved functional mobility andendurance. In contrast, the embodiment of the present invention used inthe study is designed to reduce, although it cannot completelyeliminate, conditioning in order to better isolate the effects of motortraining as an independent variable.

[0088] This initial single group design study examined the efficacy andpotential durability of a novel training protocol in patients withchronic stroke. The researchers hypothesized that the present inventionwould result in significant improvements in sensorimotor impairments,functional ability, and daily use of the paretic arm. Based on thenature of the training, they hypothesized, also, that few significantchanges would be found in strength or range of motion outcome measures.

[0089] Details of the study are as follows. A total of 14 patientscompleted the study, including eight males and six females with chronichemiparetic arm dysfunction. At the time of recruitment all patients hadlong been discharged from conventional post-stroke rehabilitation andwere at least 12 months, and a median of 30 months, post stroke.Baseline evaluations included a medical history, the FolsteinMini-Mental Status Exam, and the Orpington Prognostic Scale.

[0090] Inclusion criteria were: at least six months since a unilateralstroke, ability to follow simple instructions and two step commands,volitional control of the non-paretic arm, and at least minimalantigravity movement in the shoulder of the paretic arm. Exclusioncriteria were: symptomatic cardiac failure or unstable angina,uncontrolled hypertension (<190/110), significant orthopedic or chronicpain conditions, major post-stroke depression, active neoplasticdisease, severe obstructive pulmonary disease, dementia (MMSE<22);aphasia with inability to follow two step commands or severe elbow orfinger contractures that would preclude passive ROM of the arm.

[0091] Training consisted of 20 minutes of use of the present inventionthree times per week for six weeks (18 sessions). In each session,patients were seated comfortably at a table in front of acustom-designed bilateral arm trainer, in accordance with theembodiments of FIGS. 1-5 of the present invention, in the following limbpositions: ankles in neutral dorsiflexion, knees and hips placed at 90°,shoulders in 0° flexion, elbows in 60° flexion, and wrists in neutralposition of flexion/extension. The apparatus (see FIGS. 1-5) consistedof two independent T-bar handles that could move, nearly friction-free(without added weights or other resistance), in the transverse plane(perpendicular to the patient). The patient grasped the handles, or theaffected hand was strapped to the handle, depending on the severity ofthe deficits. By using shoulder flexion/protraction and elbow extensionthe handles were pushed away and then (using shoulderextension/retraction and elbow flexion) pulled towards the body. Thisaction mimics the behavior of reaching and bringing an object to self.When necessary, the trainer provided minimal assistance for the affectedarm, sometimes to help with the arm extension and other timesparticularly for the purpose of keeping the elbow from impacting thetable. In these cases, patients were encouraged to provide the activepushing and pulling. The handles of the apparatus were positioned atshoulder width for each patient, and a padded chest guard was adjustedto rest against the patient. The chest guard was used to prevent thepatient from utilizing their trunk while reaching forward. Recently, atleast one study has confirmed that patients with chronic hemiplegia havea significant tendency to use trunk flexion in order to reach, comparedto non-hemiplegic controls.

[0092] The training itself consisted of the following parameters: four,five-minute duration periods of use of the present invention,interspersed with 10-minute rest periods. By having the rest periodstwice as long as the exercise periods, conditioning effects werehypothesized to be reduced. Heart rate and blood pressure measurementswere taken before and after each five-minute training period to checkfor adverse cardiovascular reaction and assess for aerobic conditioning.Four active training periods enabled the session to be completed in onehour—a typical treatment time for outpatient-based occupational therapy(OT). Periods consisted of bilateral repetitive pushing/pullingmovements that were simultaneous (in-phase) for periods 1 & 3 andalternating (antiphase) for periods 2 & 4. Movements were timed to anauditory metronome set at the participant's preferred speed that wasestablished at the first session by asking patients to assume acomfortable speed that they could continue for five minutes. Thisfrequency remained constant across the entire six weeks of training,with no increase in workload, again in an attempt to reduce specificconditioning effects.

[0093] There was an eight weeks post-cessation of training period toassess retention. During this time patients were asked to do no specialtraining but to continue to use their paretic arm on activities thatthey had identified on the daily use scale (see below).

[0094] A pre-test, post-test, and retention-test consisted of thefollowing items. (1) the Fugl-Meyer Upper Extremity Motor PerformanceSection Test, selected because it assesses impairments in sensorimotorfunction. This test has been shown to be valid and reliable, and itcorrelates well with interjoint UE coordination measures in the upperextremity of patients post stroke. It has a top score of 66. FIG. 7shows the Fugl Meyer score of the 14 patients. (2) The Wolf MotorFunction Test, selected because it reliably measures functional abilityin a variety of activities and appears to be more sensitive than otherupper extremity tools. On this test, timed items assess speed ofperformance. The ability to lift a weight assesses functional strengthand quality of motor function is assessed using a five-step ordinalscale. FIG. 8 presents the Wolf Function score for 11 patients. (3) Acustom-designed questionnaire, the University of Maryland ArmQuestionnaire for Stroke (UMAQS), has been developed to assess daily useof the paretic arm in accomplishing activities of daily living (ADL's)based on a five-point ordinal scale that grades degree of independence.The top score is 50. This questionnaire differs from the FunctionalIndependence Measure by measuring daily use rather than level ofassistance and from the Motor Activity Log because it accounts forunilateral and bilateral tasks, as well as considering handedness. FIG.9 shows the UMAQS score of II patients. Types of activities includetypical ADL's, as well as lifting, carrying, and pulling a two-handleddrawer. Activities that are hand specific and complementary (e.g.,eating with a fork in the dominant hand and supporting a plate with thenon-dominant hand) are on separate, but equivalent, questionnaires thatare administered according to whether the affected hand was dominant ornon-dominant pre-stroke. The researchers also graded patientsatisfaction and perceived improvement based on five-point scales toprovide patient self-report of the effectiveness of using the presentinvention. The UMAQS is currently being tested for reliability andvalidity, including caregiver confirmation regarding the accuracy of theresponses. (4) Isometric strength of the shoulder(flexion/extension/abduction), elbow (flexion/extension), wrist(flexion/extension) and thumb opposition was measured using theChatillon Force Dynamometer, manufactured by Chatillon of New York andgrip strength using the BASELINE Hydraulic Hand Dynamometer,manufactured by BASELINE of New York. (5) Active ROM/Passive ROM(AROM/PROM) of the upper extremities was determined using standardgoniometry, which has been demonstrated to be reliable and sensitive(within 5°).

[0095] The initial analyses were a one-way repeated measures ANOVAS tocompare the pre-, post-(six weeks training) and retention (eight weekspost-cessation of training) test measures on the dependent variables.Significant results were further investigated with post hoc (Tukey HSD)comparisons. Subjects 1-3 did not undergo retention testing or the Wolfand UMAQS tests since these were added to the protocol later. Therefore,non-significant results were duplicated with a one-way repeated measuresanalysis to compare pre-post on all 14 subjects. Alpha level was set at0.05.

[0096] The characteristics of the subject pool completing the study areshown in Table 1. All but one subject (#7) had more than trace movementat the shoulder, but only three subjects could extend the finger jointsby at least 10° or the wrist joint by at least 20°. The group meanincrease in training heart rate summed across sessions 1, 6, 12 and 18was unchanged at 2.7 beats (+/−3.1). Notwithstanding the fact that somepatients were on medications that would influence these results, therewas no indication of an aerobic training adaptation. TABLE 1Characteristics of Subject Population Months Side since of HandOrpington Subject Age Gender CVA CVA Dom. Category MMSE  1 62 Female 26Left Right Mod 15*  2 60 Male  29 Right Right Min 28  3 44 Female  30Right Right Mod 23  4 60 Male  40 Right Left Min 26  5 89 Male 192 LeftRight Min 27  6 68 Male 204 (1^(st)) Left Left Mod 21  39(2^(nd))  7 80Female  18 Right Right Severe 30  8 70 Male  59 Right Right Min 28  9 67Male 360 Right Right Mod 26 10 49 Female  29 Left Right Mod 29 11 62Female  31 Left Left Min 30 12 44 Female  23 Left Right Min 28 13 65Male  46 Right Right Mod 30 14 73 Male  14 Left Right Min 22

[0097] The Fugl-Meyer Upper Extremity Motor Performance Section Testscores showed significant improvements (p<0.004). Post-hoc analysisrevealed that both the post- and retention-test scores were higher thanthe pre-test score (reflecting an 18% and 26% increase, respectively,and effect sizes of 0.41 and 0.66) (See FIG. 7). Wolf Motor FunctionTest scores for performance time showed significant improvements overthe three testing periods (p<0.02). Post hoc analysis revealed that boththe post- and retention-test scores were significantly higher than thepre-test score (reflecting a 12% and 13% increase, respectively, andeffect sizes of 0.20 and 0.20) (See FIG. 8). Neither the weight nor thequality of function aspects of the Wolf test revealed significantdifferences, although both showed a trend for improvement. The UMAQSquestionnaire section on daily use showed significant improvements overthe three testing periods (p<0.002). Post hoc analysis revealed againthat post- and retention-test scores were significantly higher than thepre-test score (reflecting a 42% and 43% increase, respectively, andeffect sizes of 0.52 and 0.55) (See FIG. 9). The relatively small samplesize precludes drawing any conclusions concerning the effect ofpre-morbid handedness and side of CVA.

[0098] The patient satisfaction section of the UMAQS revealed that allbut one subject (#7) reported that they were either satisfied or verysatisfied with the training. Similarly, all but subject #7 reported thatthey had improved a little or a lot after training. These ratings weremaintained at the retention period. Subject #7 was the only subject whomade no improvement throughout the training. She was also the only onewith a severe categorization from the Orpington Prognostic Scale andbarely trace movement. Patients also reported the following: “I can usemy arm more”; “I can feel my arm more”; “I can hold onto things now”; “Ican do things with two hands”; and “I feel like I have two arms again”.

[0099] Four out of 16 strength measures revealed significantimprovements. For the paretic arm, elbow flexion (p<0.05 but no post hocdifferences) and wrist flexion (pre vs. post=p<0.02) were significant.For the non-paretic arm, elbow flexion (p<0.02; pre vs. retention) andwrist extension (p<0.02; pre vs. retention) were significant. Four outof 28 AROM and PROM measures revealed significant improvements. For theparetic arm, AROM for shoulder extension (p<0.01; pre vs. post), wristflexion (p<0.004; pre vs. post) and thumb opposition (p<0.002; pre vs.post/pre vs. retention) were significant. For the paretic arm, also,PROM for wrist flexion (pre vs. post=0.03) was significant. Table 2displays the mean values of these significant changes in strength andROM. TABLE 2 Significant Changes in Mean Strength and Range of MotionMeasures Retention Pretest Post-test Pretest Post-test Test Measure (n =14) (n = 14) (n = 11) (n = 11 ) (n = 11) Strength* Paretic arm Wristflexion 4.58 6.35 Elbow flexion 7.93 9.28 9.77 Non-paretic arm Wristextension 9.40 10.45 11.84 Elbow flexion 12.95 14.17 16.55 ROM† Pareticarm Active Shoulder 39.55 48.45 44.10 extension Wrist flexion 23.2736.36 27.91 Thumb .91 1.36 1.45 opposition‡ Paretic arm Passive Wristflexion 71.21 75.57

[0100] In this single group design study, the researcher found six weeksof use of the present invention improved several key measures ofsensorimotor impairments functional ability (performance time), andfunctional use in patients with chronic UE hemiparesis. Furthermore,these improvements were maintained at two months after patients stoppedtraining, suggesting the motor improvements were potentially durable.This supports the hypothesis that forced-use in a repetitive stereotypictraining program, in this case bilaterally, improves motor function inchronic hemiparetic stroke patients that have long since completedconventional training.

[0101] A rationale as to why active bilateral UE training with thepresent invention is successful includes the following. Practicingbilateral movements in synchrony (and in alternation) may result in afacilitation effect from the non-paretic arm to the paretic arm. Forexample, when initiating bimanual movements simultaneously, the arms actas a unit that supercedes individual arm action, indicating that botharms are strongly linked as a coordinative unit in the brain. It is wellknown that even if one arm or hand is activated with a moderate force,this can produce motor overflow in the other such that both arms areengaged in the same or opposite muscle contractions although atdifferent levels of force.

[0102] Furthermore, studies have shown that learning a novel motor skillwith one arm will result in a bilateral transfer of skill subsequently,to the other arm. Taken together with the knowledge gained with use ofthe present invention a strong neurophysiological linkage in the CNS issuggested.

[0103] An aspect of the present invention, as used in this study, is therhythmic repetition of an action via auditory cueing. Repetition, or“time on task” is a well-known motor learning principle, and recentanimal studies have demonstrated that “forced use” involving arepetitive motor task rather than forced-use alone may best promotecentral neural plasticity. Rhythmic auditory cueing has threeadvantages. First, by holding frequency constant, it ensures that thesame movement is actually repeated. In effect, the auditory cueing mayentrain the motor system to its beat. Second, trying to match the soundwith full extension or flexion provides an attentional goal for thepatient. Goal setting is also known to promote motor learning. Onerecent study demonstrated the efficacy of having a real object (goal) toreach for in patients with hemiparetic arms. Third, receiving feedbackhas been shown to be fundamental to motor learning. In this experiment,sensory information from the audio cues, as well as that from visual andsomatosensory sources, provided intrinsic feedback to the patientregarding the movement goal. Collectively, it is plausible that thetechniques employed involving repetition and cueing, based as they areon motor learning principles in non-hemiparetic persons, may alsocontribute to motor re-learning in the hemiparetic case.

[0104] The researchers' initial findings suggest that even patients withquite severe UE hemiparesis can benefit from a program using the presentinvention, in contrast to what is suggested in some of the prior art.Constraint-induced (CI) protocols require subjects to have a fair degreeof voluntary movement. For example, in some prior studies, patients havebeen excluded if they could not achieve at least 10° of active extensionat the metacarpophalangeal and interphalangeal joints of the hand and20° of active extension at the wrist of the affected limb. Other priorstudies have required subjects to actively initiate wrist and fingerextension on the hemiparetic side. Similar criteria applied to pre-testAROM measures for the study, in accordance with the present inventionwould have excluded 11 of the 14 subjects. Though it is not yetestablished whether the CI paradigm may be beneficial to patients thatare not highly functioning, the results of this study suggest that aprotocol using the present invention improves motor function in patientswith much denser UE hemiparesis. This expands the applicability offorced-use, task-oriented training across a broader deficit severityspectrum in chronic stroke.

[0105] Also in contrast to the suggestions of the prior art the trainingprotocol of the present study demonstrates that gains can be attainedover a relatively brief training period. The time spent training thearms, six hours, is about one tenth of the intervention time used in theCI paradigm, although the treatment time period of the latter is shorter(two weeks vs. six weeks). Conceivably, the distributed practice in thepresent study (72 periods of five minutes) vs. the massed nature of theCI paradigm (10 periods of 360 minutes) contributed to the former'ssuccess over a shorter exercise time. Regardless, the present studydemonstrates the surprising result that functional gains in a chronicparetic arm can be achieved after only six hours total training, leavingthe possibility that longer training periods, or other variations of useof the present invention, including progressive or incremental resistivecomponents, could result in greater motor and functional gains.

[0106] Prior studies have argued that changes that occur quickly afterpractice represent either an “unmasking” of dormant neuromuscularpathways or cortical reorganization and sensorimotor learning of newneural pathways. Re-conditioning of the neuromuscular system byreversing disuse atrophy may contribute to functional gain. Although nodirect measures of conditioning were taken with the study using oneembodiment of the present invention, physiological changes at the levelof skeletal muscle, such as hypertrophy, and change in fiber type arenot expected within this time frame and at such low intensity training.Indeed, the researchers for this study, using one embodiment of thepresent invention, observed few changes in strength measures aftertraining or at retention testing. For example in the paretic arm, wristflexion improved after training, but was not retained. Evidently theaction of pulling the handle towards the body produced this temporarygain. Temporary gains were also seen in the AROM of shoulder extensionand wrist flexion of the paretic arm. Only AROM for paretic thumbopposition was a retained gain. In the non-paretic arm, elbow flexionand wrist extension were strengthened, but not significantly so untilafter the training had finished (making these data hard to interpret).Overall, the few largely temporary strength and ROM changes are notsupportive of large muscular conditioning effects, as expected given thetraining protocol.

[0107] In a subsequent single case study, structural and brainactivation images obtained from a 62 year old patient two years aftersuffering a complete right MCA ischemic stroke demonstrated activationof new foci in primary and premotor cortices in both hemispheres inducedby six weeks of training using the present invention. This supports theidea that bilateral arm training does result in central neural changes,rather than peripheral muscle changes.

[0108] In conclusion, this study suggests that a regimen using thepresent invention, based on motor learning principles, leads tosignificant and potentially durable functional gains in the paretic UEof chronic hemiparetic patients. The present invention is appropriatefor patients with greater baseline severity motor deficits than areamenable to CI treatments of the prior art. Moreover, the interventionis not prohibitively complex, and hence may be feasible for home-use bymany patients.

[0109] Example embodiments of the present invention have now beendescribed in accordance with the above advantages. It will beappreciated that these examples are merely illustrative of theinvention. Many variations and modifications will be apparent to thoseskilled in the art.

What is claimed is:
 1. A device for bilateral upper extremity training,comprising: a base; a pair of sliding tracks attached to the base; and apair of handles slidably movable along the sliding tracks, wherein thehandles are unyoked and have minimal resistance for movement along thetracks.
 2. The device of claim 1, further comprising: a chest restconnected to the base.
 3. The device of claim 1, further comprising: apair of swivel plates connected to the base; wherein the pair of slidingtracks are attached to the base via the pair of swivel plates.
 4. Thedevice of claim 1, wherein the pair of sliding tracks are separated by asliding tracks separation distance, and wherein the sliding tracksseparation distance is variable.
 5. The device of claim 4, furthercomprising: a pair of width plates, each of the width plates beingseparated by a width plate separation distance, the width plateseparation distance being variable; wherein the pair of sliding tracksis attached to the base via the pair of width plate, and wherein thesliding tracks separation distance varies as a function of variation ofthe width plate separation distance.
 6. The device of claim 5, furthercomprising: an incline plate attached to the base; wherein the pair ofwidth plates is attached to the base via the incline plate.
 7. Thedevice of claim 6, wherein the pair of width plates is attached to theincline plate via at least a pair of connecting devices.
 8. The deviceof claim 7, wherein each of the pair of width plates includes at leastone slot, and wherein one of the at least a pair of connecting devicesextends through each of the at least one slot.
 9. The device of claim 1,wherein the pair of sliding tracks is inclinable relative to the base.10. The device of claim 9, wherein the pair of sliding tracks isattached to the base via a pivoting device, and wherein the pair ofsliding tracks is inclinable relative to the base via the pivotingdevice.
 11. The device of claim 6, wherein the pair of sliding tracks isinclinable relative to the base.
 12. The device of claim 11, wherein thepair of sliding tracks is inclinable relative to the base via theincline plate.
 13. The device of claim 1, wherein the pair of handles isslidably movable along the sliding tracks via a pair of frictionreduction devices.
 14. The device of claim 13, wherein the pair offriction reduction devices comprises bearings.
 15. The device of claim13, wherein the pair of friction reduction devices comprises wheels. 16.A device for bilateral arm training for a user, comprising: a pair ofconnected swivel plates, each of the swivel plates being independentlyswivelable about a point on the swivel plate, such that each of theswivel plates may be swiveled to a selected angle, wherein the connectedpair of swivel plates has a first end and a second end; a pair ofsliding tracks attached to the pair of swivel plates; a pair of handlesslidably movable along the sliding tracks; an incline device connectedto the first end of the pair of swivel plates, such that the pair ofswivel plates may be inclined relative to the second end of the pair ofswivel plates; and a user distancing device connected to the second endof the pair of swivel plates, the user distancing device for maintainingthe user at a set distance while the user grasps the pair of handles;wherein the pair of sliding tracks may be adjusted by inclination of thepair of swivel plates and by swiveling of the pair of swivel plates,such that a variable range of motions may be made by the user via thepair of handles.
 17. The device of claim 16, further comprising: anincline plate the pair of connected swivel plates being connected viathe incline plate.
 18. The device of claim 17, further comprising: apair of width plates, each of the pair of width plates being attached toone of the pair of connected swivel plates, and wherein the pair ofwidth plates are each attached to the incline plate.
 19. The device ofclaim 18, further comprising: a base pivotably coupled to the inclineplate.
 20. The device of claim 19, wherein the base is pivotably coupledto the incline plate by at least one hinged connector.
 21. The device ofclaim 16, wherein the user distancing device comprises a chest rest. 22.The device of claim 21, wherein the user distancing device comprises anadjustable height portion and an adjustable distancing portion.
 23. Thedevice of claim 22, wherein the adjustable height portion includes a rodand a clamping device.
 24. The device of claim 16, wherein the user hasa torso and upper extremities and wherein the user distancing deviceisolates movement in the upper extremities from movement in the torso.25. The device of claim 17, wherein the incline device comprises anincline rod and an incline rod clamp, and wherein the incline rod clampis attached to the incline plate.
 26. The device of claim 16, furthercomprising: a pair of movement blocks movably coupled to the pair ofsliding tracks; wherein the pair of handles are attached to the pair ofmovement blocks.
 27. The device of claim 26, further comprising: a pairof movement stops fixably attachable to the pair of sliding tracks;wherein the pair of movement stops stops movement of the pair ofmovement blocks along the pair of tracks.
 28. The device of claim 16,further comprising: a counter for counting movements of at least one ofthe pair of handles.
 29. The device of claim 27, further comprising: acounter for counting movements of the at least one of the pair ofhandles, the counter being attached to one of the pair of movementstops.
 30. The device of claim 20, wherein the pair of swivel plates areattached to the pair of width plates by at least two removableconnectors.
 31. The device of claim 30, wherein each of the at least tworemovable connectors comprises a threaded extension.
 32. The device ofclaim 31, wherein each of the pair of swivel plates includes an arcedslot; wherein for each of the pair of swivel plates, a first one of theremovable connectors extends through the arced slot; wherein a secondone of the removable connectors extends through a non-slotted opening;and wherein each of the swivel plates swivels about the non-slottedopening about the arced slot.
 33. The device of claim 31, wherein eachof the pair of width plates is attached to the incline plate by at leasttwo removable connectors.
 34. The device of claim 33, wherein each ofthe pair of width plates is attached to the incline plate via at leasttwo slotted openings; and wherein, for each width plate, each of the atleast two removable connectors attaches the width plate to the inclineplate via one of the at least two slotted openings.
 35. The device ofclaim 16, wherein the incline device comprises at least one blockinsertable beneath the first end of the pair of connected swivel plates.36. The device of claim 21, wherein the chest rest comprises a flexiblematerial.
 37. The device of claim 16, further comprising an auditorycueing device.
 38. The device of claim 37, wherein the auditory cueingdevice comprises a metronome.
 39. The device of claim 16, furthercomprising a visual cueing device.
 40. The device of claim 39, whereinthe visual cueing device comprises a mirror.
 41. A bilateral arm trainerfor a user, comprising: a base securable to a fixed surface; an inclineplate pivotably attached to the base; a first width plate and a secondwidth plate, the first width plate and the second width plate beingadjustably attached to the incline plate; a first swivel plate and asecond swivel plate, the first swivel plate being attached to the firstwidth plate and the second swivel plate being attached to the secondwidth plate, wherein the first swivel plate is swivelable about a firstswivel plate point relative to the first width plate, and wherein thesecond swivel plate is swivelable about a second swivel plate pointrelative to the second width plate; a first track attached to the firstswivel plate and a second track attached to the second swivel plate; afirst handle movable along the first track and a second handle movablealong the second track; an incline device for pivotably inclining theincline plate relative to the base; and an adjustable chest restattached to the base for maintaining the user at a set distance whilethe user grasps the pair of handles; wherein the first track and thesecond track are adjustable by inclination of the incline plate andswiveling of the first swivel plate and the second swivel plate, suchthat a variable range of motions may be made by the user via the pair ofhandles.
 42. A bilateral arm trainer for a user, comprising: a basesecurable to a fixed surface; an incline plate pivotably attached to thebase; a first width plate and a second width plate, the first widthplate and the second width plate being adjustably attached to theincline plate; a first swivel plate and a second swivel plate, the firstswivel plate being attached to the first width plate by a first swivelplate pivoting device and the second swivel plate being attached to thesecond width plate by a second swivel plate pivoting device, wherein thefirst swivel plate is pivotable relative to the first width plate, andwherein the second swivel plate is pivotable relative to the secondwidth plate; a first track attached to the first swivel plate and asecond track attached to the second swivel plate; a first handle movablealong the first track and a second handle movable along the secondtrack; an incline device for pivotably inclining the incline platerelative to the base; and an adjustable chest rest attached to the basefor maintaining the user at a set distance while the user grasps thepair of handles; wherein the first track and the second track areadjustable by inclination of the incline plate and pivoting of the firstswivel plate and the second swivel plate, such that a variable range ofmotions may be made by the user via the pair of handles.
 43. A method ofrestoring a degree of neurologic function for at least one upperextremity of a human individual who has lost some degree of neurologicfunction for the extremity subsequent to stroke, by employing the deviceof claim 1, the method comprising: having the user repetitively move atleast one from a group consisting of the first handle and the secondhandle along at least one from a group consisting of the first track andthe second track for a period of time sufficient to restore a degree ofneurologic function for the extremity.
 44. A method for corticalremodeling and sensorimotor relearning for a person suffering fromneurological damage caused by one from a group consisting of stroke,tumor, injury, and cerebral palsy, the neurological damage resulting indiminished movement of at least one upper body extremity, the methodcomprising: moving a pair of unyoked handles along a pair of slidingtracks, wherein the sliding tracks are attached to a base, wherein thehandles move with a minimum of resistance along the sliding tracks for aperiod of time, and wherein the moving of the pair of unyoked handlesunmasks neural pathways.
 45. The method of claim 44, wherein moving thepair of unyoked handles occurs in rhythm with an audible cue.